The Food and Drug Administration on Thursday delivered a split decision on GSK’s blood cancer drug, Blenrep, approving its use in one combination regimen while rejecting another. This mixed ruling marks a significant moment in the drug’s turbulent history, particularly in the treatment landscape for multiple myeloma.
GSK had submitted various Blenrep combinations for FDA consideration, targeting patients with multiple myeloma who had previously undergone at least one other therapy. The approved regimen was evaluated in the DREAMM-7 trial, while the rejected combination was assessed in the DREAMM-8 study. Both trials indicated that Blenrep effectively reduced the risk of disease progression or death, with DREAMM-7 also showcasing an improvement in overall survival. The implications of this ruling could influence treatment protocols and patient access to Blenrep, as healthcare professionals navigate the complexities of multiple myeloma therapies.
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